Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC)

February 26–27, 2018

Agenda

February 26, 2018

8:30 a.m. Welcome and Opening Remarks
Catherine Spong, M.D.
8:35 a.m. Review and Approval of Minutes from November's Meeting
Catherine Spong, M.D.
8:40 a.m. Introduction of Task Force members
8:45 a.m. Summary and Discussion of Work Products from Meetings 1 and 2
8:45 a.m. Review of Work Products and Recommendations from Meetings 1 and 2
Catherine Spong, M.D.
9:15 a.m. Discussion
9:45 a.m. BREAK
10:00 a.m. Public Comment Period
10:45- a.m. Panel: Lessons Learned from Pediatric Research

Brief Overview of Presentations
10:45
Community involvement/groundswell
Mark Del Monte, J.D.
 
10:55
Best Pharmaceuticals for Children Act (BPCA) overview (PDF 182 KB)
Anne Zajicek, M.D., Pharm.D., FAAP
 
11:05
NIH and BPCA (PDF 263 KB)
Perdita Taylor-Zapata, M.D.
 
11:15
FDA and BPCA (PDF 261 KB)
Lynne Yao, M.D., FAAP
 
11:25
Industry perspective (PDF 1.9 MB)
Samuel Maldonado, M.D., M.P.H., FAAP
 
11:35 a.m. Discussion
Moderator: Andrew Bremer, M.D., Ph.D.
12:15 p.m. LUNCH
1:15 p.m. Effective Communication Strategies with Health Care Providers and the Public on Information Relevant to Pregnant Women and Lactating Women
1:15 p.m. Communication Strategy Case Example: NICHD Safe to Sleep® Campaign (PDF 1 MB)
Lorena Kaplan, M.P.H., CHES
1:50 p.m. Panel: Effective Communication Strategies with Health Care Providers on Information Relevant to Pregnant Women and Lactating Women

Brief Overview of Presentations
1:50
Federal perspective
John Whyte, M.D., M.P.H.
 
2:00
Professional society perspective (PDF 510 KB)
Kerri Wade, M.P.A.
 
2:10
Industry perspective
Susan Kindig, M.D., J.D.
 
2:20
Health care provider perspective (PDF 225 KB)
Susan Givens, RNC-OB, M.P.H., LCCE
 
2:30 p.m. Discussion
Moderator: Jeanna Piper, M.D.
Additional panelists:
Jeanne Sheffield, M.D., and Victoria Pemberton, RNC, M.S., CCRC
3:15 p.m. BREAK
3:30 p.m. Panel: Effective Communication Strategies with the Public on Information Relevant to Pregnant Women and Lactating Women

Brief Overview of Presentations
3:30
Federal perspective (PDF 4 MB)
Jackie Rosenthal, M.P.A.
 
3:40
Professional society perspective (PDF 1 MB)
Bridgette Jones, M.D.
 
3:50
Professional organization perspective (PDF 1.3 MB)
Diane Spatz, Ph.D.
 
4:00
Industry perspective (PDF 338 KB)
Kristi Lengyel, M.B.A.
 
4:10
Patient perspectives (PDF 165 KB)
Susan Benjamin Feingold, Psy.D.
 
4:20 p.m. Discussion
Moderator: Karin Bok, M.S., Ph.D.
Additional panelists:Melissa Gorman, M.S.N., RN-BC, CCRN-K, and Lois Tschetter, Ed.D., RN, IBCLC, CNE
4:50 p.m. Recap of Meeting, Action Items, and Charge to Group
Catherine Spong, M.D.
5:00 p.m. END OF DAY 1

 

February 27, 2018

8:00 a.m. Recap of Day 1 and Outline and Goals for Day 2
Catherine Spong, M.D.
8:15 a.m. A Plan to Identify and Address Gaps in Knowledge and Research Regarding Safe and Effective Therapies for Pregnant Women and Lactating Women, Including the Development of Such Therapies
8:15 a.m. Discussion: Options for a Plan or Plans
Moderator: Shelli Avenevoli, Ph.D.
10:00 a.m. BREAK
10:15 a.m. Discussion Continues
Moderator: Shelli Avenevoli, Ph.D.
11:45 p.m. LUNCH
12:45 p.m. Discussion of Key Points and Review of Recommendations
12:45 p.m. Discussion of Key Points for Effective Communication Strategies with Health Care Providers and the Public on Information Relevant to Pregnant Women and Lactating Women
Catherine Spong, M.D.
1:30 p.m. Discussion of Key Points for a Plan to Identify and Address Gaps in Knowledge and Research Regarding Safe and Effective Therapies for Pregnant Women and Lactating Women, Including the Development of Such Therapies
Catherine Spong, M.D.
2:15 p.m. Review of Recommendations from Meetings 1, 2, and 3
Catherine Spong, M.D.
2:45 p.m. Recap of Meeting, Action Items, and Charge to Group (PDF 168 KB)
Catherine Spong, M.D.
3:00 p.m. END OF DAY 2, ADJOURN MEETING

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